Associate Director Regulatory Affairs

Overview

We are seeking an experienced Regulatory Affairs professional to provide strategic leadership across clinical development programs. This role serves as a key liaison with Health Authorities and drives regulatory strategy, planning, and execution for complex submissions throughout the product lifecycle.

Key Responsibilities

• Serve as Regional Regulatory Lead (US) for assigned development programs
• Develop and execute regulatory strategies aligned with project goals
• Lead the planning, preparation, and submission of regulatory dossiers (e.g., INDs, briefing documents, orphan/fast track applications, pediatric study plans)
• Act as the primary liaison with FDA, managing communications and interpreting regulatory feedback
• Oversee submission timelines, content, and quality to ensure compliance and on-time delivery
• Collaborate cross-functionally with clinical, CMC, and program teams
• Monitor and interpret evolving regulatory requirements and assess impact on programs
• Support innovative regulatory pathways, including rare disease development strategies

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biological Sciences, or related field
• 6+ years of experience in the pharmaceutical/biotech industry, including 4+ years in Regulatory Affairs
• Strong knowledge of FDA regulations and global regulatory frameworks
• Experience supporting INDs and regulatory submissions
• Demonstrated ability to develop and execute regulatory strategy
• Excellent communication and stakeholder management skills
• Strong analytical thinking, problem-solving, and ability to manage multiple priorities

Additional Skills

• Ability to work cross-functionally in a fast-paced environment
• Experience with rare disease or novel regulatory pathways preferred
• Proficiency in Microsoft Office tools